Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | 1 | 49281072410 | LA |
Abnormal vaginal bleeding (2.5 weeks too early for a period - have never had mid cycle bleeding); Large itchy red rash at injection site; Large itchy red rash at injection site; Large itchy red rash at injection site; This is a spontaneous report received from a Consumer or other non HCP. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Feb2025 at 19:00 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 18Feb2025 as dose 1, single (Lot number: 49281072410), in left arm for immunisation. The patient's relevant medical history included: "Ehlers-Danlos Syndrome" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM, start date: 01Aug2021, stop date: 21Feb2025; PRAZOSIN, start date: 01May2023, stop date: 21Feb2025. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious) all with onset 19Feb2025, outcome "not recovered" and all described as "Large itchy red rash at injection site"; VAGINAL HAEMORRHAGE (non-serious) with onset 21Feb2025, outcome "not recovered", described as "Abnormal vaginal bleeding (2.5 weeks too early for a period - have never had mid cycle bleeding)". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site erythema, vaccination site rash, vaginal haemorrhage. Additional information: The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s). Large itchy red rash at injection site starting 19Feb2025. Abnormal vaginal bleeding starting 21Feb2025 (2.5 weeks too early for a period - have never had mid cycle bleeding) The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Ehlers-Danlos syndrome
ESCITALOPRAM; PRAZOSIN